Bioequivalence and Bioavailability Forum

❝ Since you have no reference in your setting, IMHO you simply have no idea

❝ how the reference performes - or do you want to compare with literature?

Yes comparison will be done with the literature.

❝ ❝ What is the rationale (ethical as well as scientific) of this kind of

❝ ❝ study.

Is it ethical to conduct BA study on healty volunteers just to come out with best test product? In my small tenure in BA/BE field i never came across such type of study design.

IMHO establishing IVIVC can only be the scientific rationale of such type of study (For eg class II drugs in respect to Biopharmaceutics Classification System).
If i am wrong please correct me.

Regards,
Sushil